This disclosure relates to devices for closing a passageway in a body. The passageway may be a natural defect, one having occurred due to disease or trauma, or a healthy, but undesirable passageway. The subject matter of this disclosure includes methods for closing an opening in tissue, a body lumen, blood vessel, a hollow organ, or other body cavity. The disclosure also relates to occlusion devices and methods for minimally invasive implantation, in particular, percutaneous implantation, of expandable braided occlusion devices for closing passageways in the cardiovascular system.
The cardiovascular system is part of the larger circulatory system, which circulates fluids throughout the body. The circulatory system includes both the cardiovascular system and the lymphatic system. The cardiovascular system moves blood throughout the body, and the lymphatic system moves lymph, which is a clear fluid that is similar to the plasma in blood. The cardiovascular system consists of the heart and blood vessels (arteries, veins, and capillaries). It delivers oxygen and nutrients to the tissues and carries waste products to the organs responsible for elimination. The arteries carry blood from the heart to the rest of the body, and the veins carry blood back to the heart.
Initially open, and subsequently minimally invasive, surgical procedures were used to occlude vessels and lumens, particularly when symptoms were significant and drug therapy inadequate. These techniques, although often successful, were hampered by less than desirable morbidity and mortality rates, and many patients were excluded due to the severity and risks associated with these procedures. In clinical practice today, occlusion devices are generally delivered, in a collapsed state, percutaneously with a catheter through leg or arm vessels to the target vascular site or defect under fluoroscopic or ultrasonic guidance. Upon placement at the target site, the devices are allowed to expand, in situ, to an expanded state for implantation. Reduced morbidity and mortality risks have been observed using these percutaneously-delivered occlusion devices. Nevertheless, these devices may still suffer from potential drawbacks, including navigation difficulty through the catheter when collapsed, maintenance of device delivery flexibility sufficient to reliably navigate blood vessels through small diameter introducers, insufficient sealing of the vessel or defect, inadequate fixation of the device, subsequent reopening of initially occluded vessels, and inadequate provision for natural tissue ingrowth and healing following implantation. These drawbacks and others provide the impetus for the subject matter of this disclosure.